FDA Enforcement Statistics for 2016

April 21, 2017

FDA recently published enforcement metrics for FY 2016. This practice began with the publication of FY2009 data. The metrics provides a high-level overview of enforcement actions including: injunctions, seizures, warning letters and recalls conducted by all FDA Centers. This posting will look at the data from the enforcement metrics in two ways:

First, we will address the data presented in the FY2016 slide deck. These data represent all centers of the FDA: Center for Drug Evaluation and Research (CDER), Center for Biologic Evaluation and Research (CBER), Center for Devices and Radiologic Health (CDRH), Center for Veterinary medicine (CVM), Center for Food Safety and Nutrition (CFSAN) and Center for Tobacco Products (CTP).

Second, we’ve developed additional graphs from data in FDA enforcement metrics published between 2009 through 2016 that address only CDRH (devices) and CDER (drugs). We look at trends over the entire interval for a selected set of actions. Data from CBER, CFSAN, CVM and CTP are not included. CBER is not included because an overwhelming number of their enforcement actions are taken against blood and plasma entities. The figures in this section are not published in the FDA metrics although the data come from those metrics. …READ MORE…

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